Chung Ka-Fai, Yeung Wing-Fai, Yu Yee-Man, Kwok Chi-Wa, Zhang Shi-Ping, Zhang Zhang-Jin
*Department of Psychiatry †School of Chinese Medicine, University of Hong Kong ‡School of Chinese Medicine, Hong Kong Baptist University, Hong Kong SAR, China.
Clin J Pain. 2015 Oct;31(10):922-8. doi: 10.1097/AJP.0000000000000189.
Mild adverse events (AEs) are common with acupuncture, but the collection of AEs is generally poor. The objective of this study was to develop and test a new instrument for acupuncture-related AEs.
After literature review, consultation with experts, and pilot-testing, the acupuncture-related AE report form (AcupAE), a 20-item scale on local and systemic AEs was tested in 150 adults who were randomized to receive acupuncture, minimal acupuncture, and placebo acupuncture. AE was assessed using open-ended questioning, followed by the AcupAE after the third, sixth, and ninth treatment.
The incidence of any AEs per patient, as derived from the AcupAE, was 42.4% with acupuncture, 42.2% with minimal acupuncture, and 16.7% with placebo acupuncture; the respective incidence was 6.8%, 5.1%, and 3.3% with open-ended questioning. There was a significant difference in the incidence of any AEs between the 3 groups based on the AcupAE, and the incidence rates of any AEs were significantly higher when assessed by the AcupAE than by open-ended questioning in the acupuncture and minimal acupuncture groups.
The AcupAE was able to detect differences in AE between true, minimal, and simulated acupuncture, whereas the open-ended questioning was not sensitive enough. The results support the use of AcupAE as an effective instrument for the assessment of acupuncture-related AEs. Although the checklist approach can result in overreporting and the causality may be unclear for some events, it is the first step for collecting standardized information and allowing comparison between different acupuncture approaches and patient groups in future studies.
轻度不良事件（AE）在针灸治疗中很常见，但不良事件的收集情况通常较差。本研究的目的是开发并测试一种用于针灸相关不良事件的新工具。
在进行文献综述、咨询专家并进行预试验后，对150名成年人进行了针灸相关不良事件报告表（AcupAE）的测试，这是一个关于局部和全身不良事件的20项量表，这些成年人被随机分为接受针灸、微针针灸和假针灸组。通过开放式提问评估不良事件，在第三次、第六次和第九次治疗后使用AcupAE进行评估。
根据AcupAE得出，每位患者任何不良事件的发生率在针灸组为42.4%，微针针灸组为42.2%，假针灸组为16.7%；通过开放式提问得出的相应发生率分别为6.8%、5.1%和3.3%。基于AcupAE，三组之间任何不良事件的发生率存在显著差异，在针灸组和微针针灸组中，通过AcupAE评估的任何不良事件发生率明显高于开放式提问评估的发生率。
AcupAE能够检测出真针灸、微针针灸和模拟针灸之间不良事件的差异，而开放式提问不够敏感。结果支持将AcupAE用作评估针灸相关不良事件的有效工具。尽管清单法可能导致报告过多，且某些事件的因果关系可能不明确，但它是收集标准化信息以及在未来研究中允许不同针灸方法和患者群体之间进行比较的第一步。
